臨床研究ジャーナル

An Overview of the Nuremburg Code, Declaration of Helsinki and Belmont Report in the Context of Promoting Ethical Global Clinical Trial Conduct

Abstract

Veljko Kopjar

Globally, clinical trials are widely accepted as the gold standard for determining the safety and efficacy of clinical interventions. As laws and regulations vary by country and by region, standardized guidelines have been developed to promote global adherence to a set of ethical values and benchmarks with the goal of protecting research-subjects from both physical and non-physical harm. Three critical guidelines are: The Nuremburg Code, The Declaration of Helsinki and The Belmont Report. Observance of these guidelines is critical for the successful conduct of a clinical trial not only in terms of ensuring subject safety but also as it relates to promoting data integrity. However, further considerations need to be taken as it relates to artificial intelligence, wearable technologies, social media clinical trial recruitment and other 21st century solutions that are not addressed by the guidelines.